RAPID ZYME

Discs, Strips And Reagents, Microorganism Differentiation

DMS LABORATORIES

The following data is part of a premarket notification filed by Dms Laboratories with the FDA for Rapid Zyme.

Pre-market Notification Details

Device IDK813612
510k NumberK813612
Device Name:RAPID ZYME
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant DMS LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-29
Decision Date1982-02-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.